CDRH's 510(k) Working Group Preliminary Report

TAKE THE 510(K) REVIEWER SURVEY
A Cycle of Whitepapers by Nancy J Stark and Kathleen Johnson

It's been a long time coming, with complaints dating back for several years, but FDA's problems really became public when a group of FDA scientists and physicians wrote to John Podesta, head of then President-elect Barack Obama's Transition Team that "America urgently needs change at FDA because FDA is fundamentally broken...the scientific review process for medical devices...has been corrupted and distorted by current FDA managers...." The open letter was particularly significant because it was copied to six senators and four congressman and published in the national press and on every blog on the internet concerned with medical devices.

It was followed by a host of General Accounting Office (GAO) reports, the resignation of Center Director Daniel Schultz and Office of Device Evaluation Director Donna-Bea Tillman, and initiation of an Institute of Medicine (IOM) review of the 510(k) process due out in 2011.

 
Internal Assessment at CDRH
Meanwhile, the Center itself initiated a series of activities to assess the 510(k) process by establishing a 510(k) Working Group and a Task Force on Utilization of Science in Regulatory Decision Making. The Working Group and Task Force published preliminary reports in August 2010.

The working group, comprised of representatives from across CDRH, was assigned to develop an understanding of the way the 510(k) process currently functioned, the perspectives of CDRH staff and a range of external constituencies on the program, and potential areas for improvement.

As part of its research, the Working Group co-hosted a public town hall meeting called "Strengthening CDRH and the 510(k) Process" on 18 February 2010 in conjunction with the Task Force on the Utilization of Science in Regulatory Decision Making. A CD of the public meeting is available at Strengthening the Center.

510(k) Survey
To assess the consistency of CDRH reviewers’ interpretation and understanding of 510(k) regulations, guidance documents, and review practices, the Working Group conducted a survey of the Center’s premarket reviewers and managers. The survey consisted of twenty questions related to reviewers’ and managers’ knowledge and opinions on a range of areas of concern.

Reviewer Cohort. The survey was sent by email to all reviewers in CDRH’s two premarket review offices, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). All reviewers were strongly encouraged to complete it. Out of a total of 308 reviewers, 215 reviewers took the survey, and at least 162 respondents answered each question.

Manager Cohort. Premarket review managers also completed the survey as a separate cohort of respondents. Out of a total of 38 managers (Branch Chiefs, Deputy Division Directors, and Division Directors) in ODE and OIVD, 21 ODE Branch Chiefs and Deputy Division Directors took the survey, and at least 13 respondents answered each question.

Take the Survey Yourself
We've put the Working Group survey into SurveyMonkey so that you can take the it yourself, benchmark your answers against your colleagues', and then compare your answers to Center staff. It's useful and information to see if your understanding of the 510(k) clearance process is the same as the agency's. Click on survey to take the test, click on benchmark to compare your answers to your colleagues, and then Center Reviewers to see the agency's responses.

When you've finished, submit the form at the end of the survey to receive your OnDemand access to "Surviving Medical Device Recalls" presented by the Center's Bioresearch Monitoring staff.

When you need to write a 510(k), CDG has people who can help
CDG has a family of technical professionals, each with 10-15 years experience in medical devices and eager to help you write your 510(k). We have regulatory professionals for in-vivo diagnostic, in-vitro diagnostic, and non-diagnostic medical devices; regulatory engineers; a toxicologist experienced in device biological safety; statisticians; and other professionals who can contribute to 510(k) preparation. We work collaboratively with a point-person on your side so that you are involved in the process every step of the way. View our company brochure and capabilities sheet.

Contact us
Phone or email us at 773-489-5721 or cdginc@clinicaldevice.com.

Best Regards,
Nancy J Stark, PhD
President, Clinical Device Group Inc